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[Translation from Japanese to English ] At the moment we have a A version of CTD. Is there any update for this? If ...

This requests contains 160 characters . It has been translated 2 times by the following translators : ( atsuko-s , tomomo-78 , steveforest ) and was completed in 0 hours 5 minutes .

Requested by jini68jp at 25 Sep 2019 at 15:20 1943 views
Time left: Finished

今弊社で持っているのはCTDのAバージョンです。このバージョンから更新はありますか？もし更新があれば最新版を送ってください。MFの変更手続きをするに当たり、私達はPMDAにまずは簡易相談をする必要があります。その為には、CTDに変更があるかないかを確認し、最新版のCTDを元に相談をし、最終的にMFの変更ができるのです。

At the moment we have a A version of CTD. Is there any update for this?
If so, please let me have the latest version.
For amendment application of MF, we need to consult simply to PMDA first. In this case, we need to make sure any changes for CTD, referring the latest version of CTD, and the amendment of MF will be possible in the end.

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